Site Header Region
Page Header
Main Content Region

Research Protocol

Research Protocol

SSD Research Protocol Overview

Below is a research protocol for SSD at CSUSB when approached with research requests.

This proposed protocol is divided into a few sections for clarity when anticipating various types of inquiries: 

  • Guiding principles
  • Staff directives
  • A decision tree
  • The processes for each branch of the decision tree, including how decisions are made and relayed
  • Opportunity for appeal 

It is the hope of SSD that through this information there is clarity and equity in responding and engaging with research inquiries.

Overall guiding principles

Guiding Principle #1:

"IRB is a floor not a ceiling" (McDonald & Raymaker, n.d.)

Guiding Principle #2:

Is this research fair to SSD, the individuals SSD serves, and does it answer questions SSD is also seeking answers to?

Best practices

According to best practices, there are expectations for all research that involves sensitive settings and potentially vulnerable individuals such as SSD (McDonald & Raymaker, n.d.). Those include:

  • Decorum (earn trust, develop relationships, inform as equals, affirm, patience)
  • Personal accountability (researcher's work is theirs to see across the finish line, communicate early and often)
  • Collaboration (willingness, flexibility, understanding)

Staff Directive

If approached send to director. Nobody except the director or AVP can initiate the process beyond this point. Any approach for research can be responded to by “Thank you for your inquiry about research. I have forwarded it to my director who will respond to you after she reviews your request.”

Decision tree

Director will read and respond to one of the two processes below depending on if the research requests is on students or on SSD processes.

For studies involving our students

If requesting a site letter and research involvement for a study involving SSD students, it is important that your information clearly identifies features such as the research question, problem statement, recruitment protocol and research protocol in detail. Requesters should a 3-6 month lead time for consideration and approvals or feedback. Please be advised that we will only accept studies going through full IRB review.

First, a meeting or orientation will be held where disability rights and research on disabled participants will be discussed. At that time researchers will sign that they are agreeing to a full IRB if they are to proceed, that they are willing to go back into IRB and/be willing to modify research protocol if requested by the community advisory board due to community feedback.

Second, a multi-step process drawing upon evidence based processes will commence

The director and AVP of director will conduct initial review to evaluate the following:

  • Do the director and AVP wish to bring this to the board
  • will SSD director and/or AVP to be named in published works from study and see a draft with editing/input rights along with an student scholar with the differences being studied
  • Is there capacity at SSD
  • Is research funded, by who and are participants compensated
  • What type of research is this and how collaborative is it with the study participants

 

Third, research will go to community review board 

  • Is this research answering a question you have that research could help inform
  • Is this research something that promotes justice for the population involved in the research
  • what specifically do our board members with disabilities think of this potential study
  • Is there assistance available for those who may need it
  • Is this burdensome or may cause fatigue
  • Are there any stigma that may be perpetuated by this researcher

Next, research will go back to consideration with SSD/AVP to consider the following with community input

  • Does this ensure individuals as autonomous agents and reduce any power dynamics (is advising or academics involved)
  • Are there additional protections involved for a vulnerable population 
  • Does this require staff or SSD resources and is this funded if so
  • Does the research comply with the FERPA and HIPAA protections we abide by
  • What does the feedback of the community advisory board tell us about this
  • Are materials at or below 6th grade reading level for understanding and readability 
  • Are there opportunities for individuals to be involved in the research design, implementation, analysis or dissemination

As a next step in this consideration, SSD will seek input with a researcher in field (second opinion)

  • Is there scientific justification for inclusion and/or exclusion of any group
  • Discussion of any other concerns or questions

From there, feedback, thoughts and requests for revisions to proceed will be provided to prospective researcher. If the researcher wishes to proceed they will revise and resubmit. 

 

After a review for completion by SSD/AVP, the revision will go to community review board a second time with revision to answer the questions below:

  • Is this research answering a question you have that research could help inform
  • Is this research something that promotes justice for the population involved in the research
  • What specifically do our board members with disabilities think of this potential study
  • Were your prior concerns resolved

From there, if the study is approved, SSD will generate a site letter.

After the study goes through the required full IRB, there will be a final review by director and committee to ensure consistency where each group will have the opportunity a final time to address any inconsistencies

Following conducting the study, benefits to the population by providing a summary of the findings plus quarterly updates as research is conducted. 

For studies involving our staff or office or processes

For studies that involve our office but do not involve our students the process is a bit more streamlined. We will consider a full or expedited IRB review only. Please allow a 3-6 month lead time for consideration and approvals or feedback.

 

When requesting a site letter and research involvement for a study involving SSD students, it is important that your information clearly identifies features such as the research question, problem statement, recruitment protocol and research protocol in detail. 

 

First, a meeting or orientation will be held where disability rights and research on disabled participants will be discussed. At that time prospective researchers will sign that they agree that their research may be requested to be modified through this collaborative process and that they will go through either a full or expedited review but not an exempt review.

 

Next, research requests goes to director and AVP of director for initial review to consider the following:

  • Do the director and AVP wish to bring this to the board
  • Will SSD director and/or AVP to be named in published works from study and see a draft with editing/input rights along with an student scholar with the differences being referenced
  • Is there capacity at SSD
  • Is research funded, by who and are participants compensated
  • What type of research is this and how collaborative is it with the study participants

 

Next the request goes to community review board to consider the following:

  • Is this research answering a question you have that research could help inform
  • Is this research something that promotes justice for the population involved in the research
  • What specifically do our board members with disabilities think of this potential study
  • Is there assistance available for those who may need it
  • Is this burdensome or may cause fatigue
  • Are there any stigma that may be perpetuated by this research

After that, the research inquiry returns to SSD/AVP for consideration of the following:

  • Does this ensure individuals as autonomous agents and reduce any power dynamics 
  • Does this require staff or SSD resources and is this funded if so
  • Does the research comply with the FERPA and HIPAA protections we abide by
  • What does the feedback of the community advisory board tell us about this
  • Are materials at or below 6th grade reading level for understanding and readability 
  • Are there opportunities for individuals to be involved in the research design, implementation, analysis or dissemination

Consult with researcher in field (second opinion)

  • Is there scientific justification for inclusion and/or exclusion of any group
  • Discussion of any other concerns or questions

From there, feedback, thoughts and requests for revisions to proceed will be provided to prospective researcher. If the researcher wishes to proceed they will revise and resubmit. 

After a review for completion by SSD/AVP, the revision will go to community review board a second time with revision to answer the questions below:

  • Is this research answering a question you have that research could help inform
  • Is this research something that promotes justice for the population involved in the research
  • What specifically do our board members with disabilities think of this potential study
  • Were your prior concerns resolved

Study approval or declination will be delivered to researcher by SSD

If approved, SSD expects that researcher will maximize benefits to the population by providing a summary of the findings plus quarterly updates as research is conducted

If co-author, SSD director or AVP to be named in published works from study and see a draft with editing/input rights 

If declined, researcher can appeal in writing to the AVP and advisory board with any comments in writing that should be considered in the appeal

References

McDonald, K., & Raymaker, D. (n.d.). Ethical Issues in Developmental Disability Research. [presentation] https://www.aaidd.org/docs/default-source/events/mcdonald-and-raymaker-dd-research-ethics-4-19-2012-final.pdf